Acute Myeloid Leukemia, in Relapse Clinical Trial
Official title:
A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | DOSE ESCALATION STUDY Key Inclusion Criteria: - Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment. - Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system. - ECOG performance status = 1 - Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures - Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: - Patients eligible to a standard of care - Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion - Patients diagnosed with acute promyelocytic leukemia (M3) - Patients with clinically active CNS leukemia - Patients with HSCT within 100 days prior to the first administration of AB8939 - Women who are lactating/breastfeeding or who plan to breastfeed while on study - Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply EXPANSION COHORT STUDY Key Inclusion Criteria: - Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment. - ECOG performance status = 2 - Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures - Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies Key Exclusion Criteria: - Patients eligible to a standard of care - Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion - Patients diagnosed with acute promyelocytic leukemia (M3) - Patients with clinically active CNS leukemia - Patients with HSCT within 100 days prior to the first administration of AB8939 - Women who are lactating/breastfeeding or who plan to breastfeed while on study - Women with a positive pregnancy test Other protocol-defined inclusion/exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
France | Institut Paoli Calmettes | Marseille | |
Greece | National and Kapodistrian University of Athens NKUA · Department of Hematology and Bone marrow Transplantation Unit | Athens | |
Spain | General University Hospital of Alicantet (Hospital General Universitario Dr. Balmis de Alicante) | Alicante | |
Spain | Hospital San Pedro de Alcantara | Cáceres | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario Quirónsalud | Madrid | |
Spain | MD Anderson Cancer Center Madrid | Madrid | |
Spain | Clínica Universidad de Navarra | Pamplona | |
Spain | Virgen del Rocío University Hospital (Hospital Universitario Virgen del Rocío) | Sevilla | |
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
AB Science |
United States, France, Greece, Spain,
Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. AB8939, a Microtubule-Destabilizing Agent with Potential to Overcome Multidrug Resistance, is Active Across the Range (M0-M7) of Acute Myeloid Leukemia Subtypes. Blood (2019) 134 (Supplement_1): 5154. doi.org/10.1182/blood-2019-127021
Goubard A, Humbert M, Mansfield C, Hermine O, Dubreuil P, et al. In Vivo Assessment of the Next Generation Microtubule-Destabilizing Agent AB8939 in Patient-derived Xenograft Models of Acute Myeloid Leukemia. Blood (2019) 134 (Supplement_1): 5142. doi.org/10.1182/blood-2019-127143
Humbert M, Goubard A, Mansfield C, Hermine O, Dubreuil P, et al. Anticancer Activity of a Highly Potent Small Molecule Tubulin Polymerization Inhibitor, AB8939. Blood (2019) 134 (Supplement_1): 2075. doi.org/10.1182/blood-2019-122540
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of dose limiting toxicity (DLT) | Identification of the Maximal Tolerated Dose for different dosing schedules | Up to 56 days | |
Secondary | Objective Response Rate | The proportion of patients who have a partial or complete response to therapy | Up to 56 days |
Status | Clinical Trial | Phase | |
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